The present invention generally relates to the field of devices that temporarily occlude spaces within the body to provide a therapeutic effect.
According to 2010 World Health Organization data, 198 million Americans over the age of 15 are above target weight. Of these individuals, 89 million are considered overweight (25<Body Mass Index<30) and 109 million are considered obese (Body Mass Index>30). Worldwide, more than 1.4 billion adults age 20 and over are overweight, and 500 million are obese. Obesity places patients at increased risk of numerous, potentially disabling conditions including type 2 diabetes, heart disease, stroke, gallbladder disease, and musculoskeletal disorders 1, 2, 3. Compared with healthy weight adults, obese adults are more than three times as likely to have been diagnosed with diabetes or high blood pressure 4. In the United States it is estimated that one in five cancer-related deaths may be attributable to obesity in female non-smokers and one in seven among male non-smokers (>=50 years of age). On average, men and women who were obese at age 40 live 5.8 and 7.1 fewer years, respectively, than their healthy weight peers.
Gastric bypass surgery is the current gold standard treatment for patients with a body mass index (“BMI”) of greater than 40. Gastric bypass surgery is also an option for those with a BMI between 35-39 with obesity-related co-morbidities. While gastric bypass surgery results in decreased food consumption and weight loss for a majority of recipients, it requires life-altering, permanent anatomic modifications to the gastrointestinal tract and can result in severe complications. Gastric bypass and related surgical procedures are also expensive, costing about $22,500 (by laparoscopy). For these reasons, only about 250,000 surgical obesity procedures are performed per year in the US.
For the vast majority of the overweight and obese population for whom surgical obesity procedures are not appropriate, few efficacious and affordable interventions are currently available. Diet and exercise remain the front line approaches to obesity, however this approach has at best slowed the growth of the epidemic. To date, drug therapies have dose limiting side effects or have lacked meaningful long term efficacy.
One less-invasive intervention that has begun to gain popularity is an intragastric balloon. Intragastric balloons can be placed endoscopically or positioned using other methods and generally must be removed endoscopically or rely on the body's natural digestive processes for removal. Many intragastric balloons are placed endoscopically because they are too difficult for the typical patient to swallow.
The present invention also includes devices and systems that generally relate to the ingestion of objects by swallowing and the field of oral delivery of compositions or apparatuses. More particularly, the invention relates to the oral delivery to the stomach of objects, including large volume objects, with greater ease than is achieved with conventional oral dosage forms. The devices can also be delivered to any part of the body, including but not limited to the digestive tract and/or the gastro intestinal system.
Typically, the “size OOO” capsule is the largest volume dosage form administered to adult, human patients. It is cylindrical and symmetrical with rounded ends. The OOO capsule's maximum enclosed payload is about 1.37 ml, its outer diameter is 9.97 mm and its height (“locked length”) is 26.4 mm. Typically, manufacturers of medical devices that must be swallowed have sought to replicate the OOO capsule. For example, the PillCam® SB video capsule from Given Imaging Ltd has an outer diameter of 11 mm and a height of 26 mm.
The human capacity to swallow a particular volume of a given material is a function of a number of factors including that material's shape and consistency (that is, what it feels like to the mouth and throat). A highly deformable material, such as a raw oyster, can be comfortably swallowed in volumes nearing 20 milliliters. On the other hand, rigid objects can typically only be comfortably swallowed (if at all) in substantially lower volumes; in fact a meaningful proportion of human patients report difficulty in swallowing even the smallest pills when in a particularly hard format.
A number of technologies have been described that are intended to render swallowing more facile, particularly for individuals with compromised swallowing abilities. In U.S. Pat. No. 3,418,999, Davis describes a method of swallowing a pill with a density less than 1 floating on a pool of water in the mouth. The floating pill is swallowed with the head in a downwardly bowed position.
Others have proffered mechanical barriers to prevent induction of the gag reflex during attempted swallowing. In U.S. Pat. No. 5,643,204, Cover teaches an intraoral shield over the soft palate held in place by incorporated tooth imprints. The shield is intended to prevent pills in the mouth from contacting gag-reflex-activating tissue.
Others teach softening and/or lubricating the oral dosage form to facilitate swallowing. In U.S. patent application Ser. No. 10/590,282, Soltero teaches incorporation of a gelatinous, hydrated polymeric matrix that facilitates swallowing due to its gelatinous consistency and textural properties. In a similar vein, in U.S. patent application Ser. No. 12/866,715, Craig et al. teach an at least partial surface covering for a traditional capsule comprising a lubricating, edible gel composition to assist swallowing. In U.S. Pat. No. 6,337,083, Fuisz teaches an oral composition comprised of a base liquid and an additive such that a solid object to be swallowed is less likely to become lodged or stuck on tongue, throat, palate or esophageal surfaces of the user. In U.S. Patent RE39125, Fukui et al. teach a swallowing-assistive drink comprised of a viscous liquid or a gelatinoid of a defined viscosity intended to be consumed with medicine.
Other technologies have been described in which the dosage form is modified as to shape. For instance, in U.S. Pat. No. 8,383,135 Fuisz teaches solid dosage forms which are claimed to facilitate rapid and reliable oral, esophageal and GI transit by having a reduced surface area of the contact patch, i.e., the area of contact between the dosage form and the bodily surface (viz., having a smaller contact patch than conventional dosage forms).
These approaches are directed at improving the swallowing success of patients, particularly patients with impaired swallowing function. Further, these approaches are directed to the ingestion of pharmaceutical or neutraceutical compounds. Finally it is noted that many of these approaches are directed to means for adapting pre-existing dosage forms, for example a standard size and shape hard capsule, to be more easily swallowed by, for example, embedding the existing dosage form in a pocket of the described material.
There remains, therefore, a need for an oral dosage form that increases the maximum volume object that can be consistently swallowed with reasonable patient comfort. There also remains a need for an ingestible delivery system that is designed for the delivery of large, non-dissolvable devices, for example, gastric balloons.
The devices, methods, and systems discussed herein are intended to provide an effective treatment for obesity. Moreover, the devices, methods, and systems described herein are not limited to any particular patient population and can even be applied to clinical areas outside of obesity. The dosage form described herein can be applied to facilitate the swallowing of various medical devices other than intragastric balloons or to the swallowing, for example, of large pharmaceutical doses or larger volumes of distasteful liquids.